SFRT+Tislelizumab+Platinum Chemotherapy for Unresectable Stage III NSCLC
NCT ID: NCT07131319
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2025-04-21
2026-04-15
Brief Summary
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Will spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment increase the surgical resection rate of patients with initially unresectable stage Ⅲ non-small cell lung cancer? What adverse reactions will patients experience when receiving spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment?
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Detailed Description
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Design Type: Interventional Study Research Subjects: Patients with non-small cell lung cancer diagnosed by pathological histology or cytology, staged as stage III (T3 - 4N1 - 2M0) according to the 8th edition of AJCC, defined as initially unresectable by the multidisciplinary team (MDT), without known EGFR and ALK mutations, aged ≥ 18 years old, with an ECOG PS score of 0 - 1.
Sample Size: 30 cases
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SFRT concurrent with tislelizumab and platinum - based doublet chemotherapy
SFRT concurrent with immunochemotherapy is given q3w for 3 cycles. Here are details:
Radiotherapy: Select several 1 - cm - diameter spherical areas in the primary tumor's hypoxic region, 1.5 - 2 cm apart. Each area receives a single 12 - Gy high - dose radiotherapy, precisely targeting the hypoxic part to enhance the effect.
Chemotherapy \& Immunotherapy: 1 - 3 days after radiotherapy, combine 200 mg of tislelizumab with platinum - based doublet chemotherapy. NSCLC chemo - drug combos vary by pathology. For adenocarcinoma, use pemetrexed (500 mg/m² d1) + carboplatin (AUC 5, d1). For other types, use albumin - bound paclitaxel (100 mg/m² d1,8) + carboplatin (AUC 5, d1).
Spatially Fractionated Radiotherapy (SFRT)
Several spherical volumes (with a diameter of 1 cm) are selected within the hypoxic area of the primary tumor. The distance between each spherical volume is 1.5 - 2 cm, and a high-dose radiotherapy of 12 Gy × 1F is delivered.
Tislelizumab, Carboplatin, Pemetrexed
For adenocarcinoma, pemetrexed (500 mg/m², day 1) + carboplatin (AUC 5, day 1) is used.
Tislelizumab, paclitaxel, Carboplatin
For NSCLC with pathological types other than adenocarcinoma, nab-paclitaxel (100 mg/m² on day 1 and day 8) + carboplatin (AUC 5, day 1) is used.
Interventions
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Spatially Fractionated Radiotherapy (SFRT)
Several spherical volumes (with a diameter of 1 cm) are selected within the hypoxic area of the primary tumor. The distance between each spherical volume is 1.5 - 2 cm, and a high-dose radiotherapy of 12 Gy × 1F is delivered.
Tislelizumab, Carboplatin, Pemetrexed
For adenocarcinoma, pemetrexed (500 mg/m², day 1) + carboplatin (AUC 5, day 1) is used.
Tislelizumab, paclitaxel, Carboplatin
For NSCLC with pathological types other than adenocarcinoma, nab-paclitaxel (100 mg/m² on day 1 and day 8) + carboplatin (AUC 5, day 1) is used.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Nanchang University
OTHER
Responsible Party
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Locations
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Nanchang City, Jiangxi Province
Nanchang, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT-2025-026
Identifier Type: -
Identifier Source: org_study_id
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